Sustaining Progress Toward DSCSA Compliance Following FDA Exemptions

On October 9, 2024, the Food and Drug Administration (FDA) issued an exemption for eligible trading partners that will continue to delay enforcement regarding compliance with the Drug Supply Chain Security Act’s (DSCSA) final enhanced drug distribution security requirements. The exemption duration varies by partner type:

• Manufacturers and Repackagers: Until May 27, 2025
• Wholesale Distributors: Until August 27, 2025
• Dispensers with 26 or more full-time employees: Until November 27, 2025 (this excludes small dispensers, which are exempt until November 27, 2026)

This exemption is designed for partners who have successfully completed or made documented efforts to complete data connections with their immediate trading partners but still face challenges in exchanging data, helping to prevent delays in medication delivery. Partners using the exemption are not required to notify the FDA, ensuring smooth and continued access to medications as they implement new security measures for unit-level tracking. This exemption is only available to trading partners who have actively worked to establish data connections. Trading partners who have not taken any steps – less than 10 percent of manufacturers, according to Cencora’s estimates – must still meet the November 27 implementation deadline or obtain a WEE. However, if previously non-compliant partners can show they’ve made efforts to qualify for the exemption by November 27, they will receive it until the given deadlines.

Cencora commends the FDA’s latest decision to issue an exemption and further delay enforcement for eligible trading partners, which acknowledges the progress many partners have made while recognizing the challenges that remain across the industry.

Since the DSCSA’s introduction, Cencora has been committed to facilitating a seamless transition to comply with its requirements. We have dedicated significant time, resources and financial investments towards the deployment of technology and processes that safeguard authenticity and traceability for all pharmaceutical products that move through our systems, helping ensure that no medication goes unaccounted for. Our distribution centers are actively capturing inbound and outbound data, and we are collaborating with manufacturers to ensure they provide all necessary DSCSA data ahead of the 2025 full implementation and other key exemption expirations, making notable progress toward readiness.

In the lead-up to the original November 27 deadline, Cencora remains dedicated to helping previously noncompliant manufacturer partners establish the connectivity necessary to qualify for the exemption. In general, we will use this exemption as an opportunity to further refine our processes around serialized data sharing across the supply chain.

After a decade of progress, the goal of unit traceability for distributors, dispensers and manufacturers is within reach, and Cencora encourages all trading partners to maintain their momentum towards achieving full DSCSA compliance.

We remain poised to support trading partners in keeping their pace as they work toward meeting DSCSA requirements through this exemption. Together, we will successfully navigate this critical phase and transition into a longer-term stabilization period.

For more information on the DSCSA and how Cencora can assist, please visit: https://www.amerisourcebergen.com/dscsa